Summary of Valneva’s Expanded Access Policy
Valneva is committed to developing new prophylactic vaccines for infectious diseases with significant unmet medical need. Clinical trials are a crucial element of this effort. We believe that the best way for patients to access our investigational products is through clinical trials designed to evaluate their safety and efficacy. We believe that continuing and focusing on our clinical trial programs is the most appropriate path forward for bringing our vaccine candidates to patients as quickly and safely as possible.
Valneva aspires to collaborate with world-class medical experts in our respective areas of clinical trial investigation. Currently, it is through these trials that patients have the possibility to receive our experimental therapies.
Expanded access trials, also referred to as compassionate use programs, are another method of patient access to investigational products prior to regulatory approval and outside of clinical trials. Such programs are intended for serious or life-threatening diseases when there are no other treatment options available. While Valneva understands that it is difficult for patients with serious or life-threatening diseases to wait for regulatory approval of an investigational product, we believe that devoting and dedicating our resources to our ongoing clinical programs is the best path forward to provide patients with access to our new vaccines.
Information on applicable Valneva sponsored trials as well as investigator-sponsored trials can be found by visiting www.clinicaltrials.gov. As our clinical programs mature and we obtain clinical evidence of safety and effectiveness, Valneva might re-evaluate this policy in the future.
If you have questions about Valneva’s expanded access policy please email us at email@example.com.